Tissue biopsies are a commonly employed technique for diagnosing diseases in any of a plurality of species such as in plants and other life forms like animals, particularly in humans. Biopsies can be taken to diagnose any of a plurality of diseases, at sites including but not limited to bone biopsies (for people with bone pain and other indicators of bone cancer/neoplasm), bone marrow biopsies (for people with an abnormal blood counts, such as unexplained anemia, high white cell count, and low platelet count), breast biopsies (to confirm if a lesion is benign or malignant), cervical biopsies (to diagnose cervical cancer/neoplasm or other cervical diseases), joint biopsies (where a tissue specimen is taken from synovial membrane that lines the joint to diagnose gout, pseudogout, bacterial infections, lupus, rheumatoid arthritis or Reiter's disease), kidney biopsies (to diagnose any of a plurality of disorders), liver biopsies (to identify liver disorders and diagnose abnormalities as benign or malignant), lymph node biopsies (to diagnose diseases such as chronic lymphatic leukemia, Hodgkin's disease, infectious mononucleosis, and rheumatoid arthritis), lymph node biopsies (to diagnose if cancer has spread from a primary location into the lymphatic system), lung biopsies (to diagnose a plurality of lung diseases or abnormalities such as cancer/neoplasm or other lung diseases), pleural biopsies (to diagnose malignant and nonmalignant diseases and to diagnose viral, fungal, or parasitic diseases and collagen vascular diseases of the pleura (the sac covering the lungs)), prostate biopsies (to diagnose prostate cancer/neoplasm and/or to determine the cause of prostate enlargement or elevated, an abnormal percentage or an increasing value of serum prostate markers such as the prostate specific antigen (PSA)), small intestine biopsies (to diagnose the cause of diarrhea or poor absorption in the intestine), skin biopsies (to diagnose malignant cancer or benign neoplasm and/or chronic bacterial and/or fungal skin infections), synovial biopsies, and thyroid and/or parathyroid biopsies (to diagnose patients with thyroid enlargement and/or nodules, breathing and/or swallowing difficulties, vocal chord paralysis and/or other problems such as unexplainable weight loss).
Other biopsies that can be done include biopsies that can be done at body sites such as on the stomach, esophagus, oral cavity, pharynx, larynx, colon/rectum/anus, bladder, pancreas, spleen, central nervous system, peritoneum, genitalia and reproductive organs, heart, mediastinum, and many other sites. In addition to the reasons enumerated above for performing biopsies, any of numerous other diagnoses can be performed.
The method and the kit of the instant invention (which will be described in more detail below) are general and can be used in any of the above described biopsies (or even in biopsies that are not described above). The methods and kits of the present invention may be used for tissue biopsies, or alternatively, may be used for tissue excisions, resections, autopsies, for analyzing tissues and/or materials that are excreted and/or secreted by the patient, and tissues and/or materials that may be submitted by the patient or some other one or more entities. However, for the sake of understanding the invention, the invention will be described below with respect to a particular embodiment (i.e., prostate biopsies).
Cancer of the prostate is the most prevalent malignancy in adult males, excluding skin cancer, and is an increasingly prevalent health problem in the United States. In 1996, experts estimated that 41,400 deaths would result from this disease in the United States, indicating that prostate cancer is second only to lung cancer as the most common cause of death in the same population. The incidence of prostate cancer showed 230,110 new cases for prostate cancer in the United States in 2004. There were 975 new cases of prostate cancer per 100,000 men over 65 in the USA in the period from 1996-2000. Despite the large numbers of men affected by prostate cancer/neoplasm, if the cancer/neoplasm is diagnosed and treated early, when the cancer!neoplasm is still confined to the prostate, the chances of cure are relatively high.
Generally, diagnosis of prostate cancer/neoplasm involves detecting a relatively high level of PSA in a blood test and/or a digital rectal exam (DRE). If the level is at a level at which a physician thinks that a follow up biopsy is warranted, the physician may take a biopsy of the prostate gland. The prostate biopsy may show that the patient has BPH (benign prostatic hyperplasia) or perhaps a more serious malignant tumor.